Cleared Special

Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition

K213715 · Ge Medical Systems, LLC · Radiology

Dec 2021

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K213715 is an FDA 510(k) clearance for the Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on December 17, 2021, 23 days after receiving the submission on November 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K213715 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2021
Decision Date	December 17, 2021
Days to Decision	23 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF